AstraZeneca PLC (AZN.LN), a pharmaceutical company, and Bristol-Myers Squibb Company (BMY), a bio-pharmaceutical company, announced Monday that the European Commission has granted marketing authorisation for ONGLYZA (saxagliptin) in the 27 countries of the European Union.

MAIN FACTS:

-ONGLYZA is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control:

--in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;

--in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or

-in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.

-The marketing authorisation is based on data submitted from a comprehensive clinical development programme that included six core Phase III registrational trials and a Phase IIIB study comparing saxagliptin plus metformin with sitagliptin plus metformin.

-The registrational trials assessed the safety and efficacy of ONGLYZA and involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with ONGLYZA.

 
 
-By London Bureau, Dow Jones Newswires; Contact Ian Walker; +44 (0)20 7842 9296; ian.walker@dowjones.com